MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION VASCULAR PROBES; DILATOR, VESSEL, SURGICAL

Catalog Number 7151015

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/11/2021

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a vascular probe broke while being positioned within the coronary artery of the patient.During a coronary artery bypass graft (cabg) procedure, while trying to remove the vascular probe, the head of the probe broke in the coronary.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: the device was received for evaluation.A visual inspection was done which observed the 1.0mm tip was not present on the device.Visual inspection under magnification of the shaft with the missing 1.0 mm tip revealed the end appeared jagged and does not appear to have been cut.Additionally, it revealed the urethane coating taper was present per the defined procedure.There appeared to be no clean break that would indicate the tip or shaft had been cut, nor did there appear to be stretching of the shaft that would indicate the tip had been caught on anything within the vessel to enable the tip dislodgement.Attempts were made to recreate the failure using in-house assembled vascular probes and it was not possible to pull the tip off.The reported condition was verified.The cause of the condition could not be determined, however, there is a potential that the shaft could have inadvertently been placed only partway into the bore of the tip or that a bubble was located at the junction between the shaft and the tip.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.A device history review revealed no issues that could have caused or contributed to the reported issue.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: VASCULAR PROBES
• Type of Device: DILATOR, VESSEL, SURGICAL
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 12510621
• MDR Text Key: 272655624
• Report Number: 1416980-2021-05844
• Device Sequence Number: 1
• Product Code: DWP
• Combination Product (y/n): Y
• PMA/PMN Number: K130896
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7151015
• Device Lot Number: SP21B051505218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2021
• Initial Date Manufacturer Received: 08/25/2021
• Initial Date FDA Received: 09/21/2021
• Supplement Dates Manufacturer Received: 10/08/2021
• Supplement Dates FDA Received: 10/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1